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Issue #167: March 8, 1998
fastfax is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some information in this issue include AIDS, American Journal of Epidemiology, Archives of Neurology, Journal of AIDS and Human Retrovirology. Medical Tribune, Neurology, Philadelphia Business Journal, Philadelphia Inquirer, Reuters.ACT UP leads protest at state office building
"Crix belly" noted in new research
Hepatitis C said to speed up HIV infection
Activist challenges LA lawsuit
Researchers report advances in dementia studies
Bisexual transmission significant In heterosexual HIV
ACT UP leads protest at state office building
Almost 200 AIDS activists converged on the Philadelphia office of the Commonwealth of Pennsylvania on March 4th to demand that state officials increase Medicaid payments for AIDS-related care and add two new AIDS drugs to the state's free drug program.
Advocates for people with AIDS and other chronically-ill and disabled people have chastised the state welfare department, which runs HealthChoices, the new Medicaid managed care program, for underfunding AIDS care and making it more difficult for poor people with AIDS to gain access
to promising AIDS treatments.Earlier this month, a study commissioned by the state legislature confirmed that Pennsylvania reimbursement rates for medical care for the people with AIDS and other disabled people are too low to guarantee they will get the care they need.
Department of Public Welfare (DPW) officials have refused to add two FDA-approved non-nucleoside reverse transcriptase inhibitors -- nevirapine and delavirdine -- to the list of drugs made available for free by the state's Special Pharmaceuticals Benefits Program (SPBP). Three years ago, DPW had pledged to add new AIDS medications to the SPBP program as soon as they were approved by the FDA, the federal agency responsible for authenticating the safety and effectiveness of prescription drugs.
FDA approved the two drugs over a year ago, and Pennsylvania is one of the only states with a large number of AIDS cases which has not yet made them available to the poor.
Some PWAs have had greater success with the NNRTI drugs than with the more highly-publicized protease inhibitors.
Pennsylvania governor Tom Ridge recently added about $5.4 million to the SPBP budget, but he said that this new funding would only cover the current demand for protease inhibitors and over 50 other medications included in the program. He said that the two NNRTIs would probably be
added to the SPBP formulary by July."Gov. Ridge is creating an epidemic of death that could be prevented," said Julie Davids, a member of the Philadelphia chapter of ACT UP, the lead sponsor of protest, which was also supported by We The People. The demonstrators carried mock coffins and a huge puppet of Gov. Ridge made out to be the Grim Reaper, and for a short time blocked an entrance to the state office building before state troopers pushed them back.
"HealthChoices is killing us," said Tyrone McCray, a drummer who led a solemn procession of protesters carrying mock coffins. "Baltimore has a higher capitation rate; why can't we have one?"
The Philadelphia Business Journal reported last month that the state is, in fact, planning to increase Medicaid reimbursement rates by July, retroactive to January 1st. According to the Journal, rates may increase by as much as 7% in the second year of the three-year HealthChoices contracts. Peg Dierkers, policy director for DPW, refused to confirm the increase, saying that the state's contracts with the HMOs prohibit her from discussing specific contract terms.
According to DPW, the monthly rate paid to medical providers for care for the typical Medicaid recipient with HIV or AIDS is about $1,030. This rate is significantly lower that the monthly rate of $2,161 in Baltimore, $3,084 in Boston and $1,800 in Los Angeles.
HealthChoices has also been battered by the continuing losses suffered by the four Medicaid managed care companies which have contracts to provide care under the state program. One company, Oxford Health Plans, is undergoing major management changes and is said to be considering pulling out of the Philadelphia market. Another Oxford affiliate recently canceled its Medicaid contract in Connecticut because it was losing too much money.
Three of the HMOs -- Oxford, HealthPartners, and Healthcare Management Alternatives -- have all posted deficits of between $2.9 million and $3.5 million for the first three quarters of their state contracts, which began last February 1st.
Hospitals, doctors and other caregivers reimbursed through HealthChoices have also complained that even with the low reimbursements, they face significant delays in getting their bills paid. This controversy led several hundred doctors at Temple University Hospital to cancel its contract with HealthPartners, which has the largest number of AIDS patients in its plan. HealthPartners had previously canceled its contracts with Delaware County hospitals and has canceled the expansion of its AIDS-focused "centers of excellence" in the region, blaming the failure of HealthChoices to cover the cost of AIDS services.
Dierkers confirmed that the state will provide higher payments for AIDS care in Allegheny County and the surrounding area next year when it implements HealthChoices in the Pittsburgh area. She told the Philadelphia Inquirer that one reason for the higher rate in Pittsburgh is that HealthChoices pays Philadelphia-area HMOs beyond the capitation rate to cover the cost of the expensive new AIDS medicines known as protease inhibitors. In the other cities, the cost of protease inhibitors may be included in the capitation rate, Dierkers said.
Dierkers acknowledged to the Inquirer that in Pittsburgh the state will establish a new "risk pool" -- a separate pot of money that the HMOs there can dip into if they end up serving more AIDS patients -- but she said overall funding for AIDS patients would be comparable to that spent in the Philadelphia region.
"Crix belly" noted in new researchWhile protease inhibitors have been credited as the primary reason deaths from AIDS are dropping dramatically in the industrialized world, but success doesn't always come without some problems.
Researchers across North America are reporting the baffling development of humps of fat in people infected with HIV who are taking these drugs. The lumps appear as a "protease paunch," "horse collar" buildups around the shoulders and "buffalo humps" on the back. Crixivan users have taken to calling the phenomenon "crix belly."
At the 5th Conference on Retroviruses and Opportunistic Infections last month, several researchers presented papers on their patients' strange afflictions. But experts stressed that while the pockets of fatty tissue may give patients a cosmetic problem, there is no indication that the lumps and humps are an omen that treatment is failing.
"A good guess would be that about 5 percent of patients taking protease inhibitors develop these fatty deposits," said Dr. Richard Hengel, a senior fellow at Emory University in Atlanta. "We really don't know why they occur in our patients. We don't know why they occur in patients who don't have AIDS and aren't taking protease inhibitors."
Howard Rosenberg, a fellow in infectious diseases at Cornell University Medical College in New York, said, "Patients knew about this problem before many doctors. They talk about it on the Internet." Many of the patients are taking indinavir, or Crixivan, a Merck & Co. protease inhibitor, although the phenomenon has been seen in patients taking any kind of protease inhibitor.
Dr. Joan Lo, an endocrine disorders fellow at the University of San Francisco, said several of her patients with the fatty growths have never been on protease inhibitors, but have developed the condition while taking older drugs known as nucleoside reverse transcriptase inhibitors, such as AZT. Lo said she's concerned that patients might want to stop life-saving treatments because the deposits are disfiguring.
Dr. Jonathan Angel, of Ottawa General Hospital in Canada, already has had a patient stop taking his medication because he developed an unsightly hump. But 10 weeks after stopping therapy, the hump hasn't regressed, Angel said.
Toni Piazza-Hepp, a specialist at the U.S. Food and Drug Administration, reported on 21 cases of the humps related to protease treatment. She said the deposits are noticed by patients as soon as two months after taking the drugs. "This phenomenon has to be investigated further," Rosenberg said.
Hepatitis C said to speed up HIV infectionPatients co-infected with HIV and hepatitis C virus (HCV) appear to have a more rapid progression of HIV disease, according to a report in the March 5th issue of the journal AIDS.
A multicenter team now recommends that active management of HCV infection be considered for these patients.
Dr. Pascal Chavanet of the Hopital du Bocage in Dijon, France, and colleagues performed a longitudinal study of 119 co-infected subjects and 119 controls with HIV infection only. They followed the subjects for a median of 3 years, noting signs of clinical and immunological progression. Treatment was similar for subjects in both groups. About 42% of the subjects received two antiretroviral drugs, 59% received monotherapy, but none of the HCV-infected subjects received interferon.
Overall, Dr. Chavanet's group found that clinical progression was more rapid in co-infected patients than in patients with HIV infection only. They also found that HCV infection was a significant risk factor for both clinical and immunological progression in patients in the early stages of HIV infection.
They believe these findings indicate that interferon-based treatment is warranted, "...especially for asymptomatic patients whose CD4 count is above [600 cells per microliter], to...prevent accelerated progression of HCV and HIV diseases."
Activist challenges LA lawsuitWalt Senterfitt, a leading PWA activist in Los Angeles and board member and past president of Being Alive: People With HIV/AIDS Action Coalition of Los Angeles, has challenged the claims of the AIDS Healthcare Foundation (AHF), which has sued the County of Los Angeles for what it says is an attempt to reduce its funding because of its advocacy efforts.
The suit charges that AHF lost $700,000 for its AIDS residential programs as "retribution for a series of foundation demonstrations against the government designed to protest reductions in AIDS services."
The suit also charges that the County's AIDS Programs Office Commissioner interfered in the competitive bidding process held to award the funding.
Senterfitt, in correspondence with fastfax, noted that an article on the lawsuit in last week's issue was based primarily on information contained in an AHF press release, which had been carried by ReutersHealth news service.
"Unfortunately AHF press releases and other public statements must always be taken with a large dollop of skepticism," Senterfitt said. "This organization, arising out of community organizations but now operating much like an aggressive health care provider fighting for dominant market share, does indeed provide clinical and some other services to a significant number of HIV positive individuals dependent on public sector care. They have a number of dedicated providers. Unfortunately the president and top management have a history of intimidating those who disagree with them, and their usual solution to a problem is 'Give us more money.'"
Senterfitt said that in the recent battle against the centralization of state AIDS Drug Assistance Program services, AHF " originally hid the fact that they made a considerable profit
(or 'margin') from the difference between what they paid for drugs and what they were reimbursed by the state. They attempted to intimidate others in the AIDS services community from disagreeing with them and strongly 'urged' clients, based on one-sided information provided only by AHF, to endorse their institutionally self-interested position in letters to legislators and by attending demonstrations."
Senterfitt says that AHF is "accountable to no one, and yet they claim to advocate on behalf of Persons With AIDS. One glaring example is that they undertook an extensive campaign two years ago to lobby for mandatory testing of newborns and implicitly of pregnant women, claiming to speak on behalf of an LA AIDS community which in fact in the main strongly opposed their position."
Senterfitt called the lawsuit a tactic in a continuing battle between the County, the state and AHF as to whether or not AHF must repay funds that it received under allegedly false pretenses.
"As a PWA and a longtime advocate for access of all PWAs to a range of high-quality services, I find it unfortunate that AHF attempts to use its extensive lobbying, public relations and legal resources in its own self-interest, at frequent cost of the whole truth," Senterfitt wrote. "In fact, AHF is accountable to no one in the community and to no group of PWAs, whether or not clients of AHF. Its board meetings are closed, unless special permission is granted to attend a particular point. That is its right as a private entity, but should be clear to those observing from afar."
Researchers report advances in dementia studiesHIV-positive people with fewer than 100 CD4+ T cells per microliter and anemia or an AIDS-defining condition have a high probability of developing dementia within 2 years, according to Atlanta researchers.
Dr. Adnan I. Qureshi of Emory University and coinvestigators at the Centers for Disease Control and Prevention conducted a longitudinal review of the medical records of 19,462 HIV-positive people to detect factors associated with the development of dementia.
In the February issue of Neurology, Dr. Qureshi's group reports that such factors included "...anemia, low CD4+ T-lymphocyte count, diagnosis of an OI [opportunistic infection], blood platelet count of fewer than 100,000 cells per microliter, age 50 years or more at initial observation, and ethnicity." They also found that patients with the lowest 2-year probability of developing HIV dementia had CD4 T cell counts over 200 cells per microliter and no other risk factors.
The researchers concluded that commonly available clinical and laboratory findings can be used to estimate the probability of developing HIV dementia. Although there is currently no proven prophylactic treatment for HIV dementia, it may be possible to identify at-risk patients who could benefit from standard and experimental treatment, the researchers said.
Another study indicated that AZT may be useful in combating dementia, however, regardless of disease stage. Researchers said that AZT appears to prevent the development of HIV-related dementia, according to a report in the February 1st issue of the Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology. A team of German investigators concluded "that zidovudine is indicated in all stages of HIV infection to treat encephalopathy."
Dr. Stefan Evers and colleagues at the University of Munster conducted a prospective study of 154 HIV-positive patients without central nervous system opportunistic infection or neoplasm. They randomly assigned the subjects to 500 mg/day zidovudine or no antiretroviral therapy. Dr. Evers group also evaluated visually evoked event-related potentials (ERP) as a marker of dementia in the subjects, who were followed for up to 2 years.
Of the 98 subjects evaluated at 1-year follow-up, Dr. Evers found differences in P3, the most important ERP component, between the treated and the untreated group. In the treated subjects, P3 latency was 419 msec at baseline and 424 msec at follow-up, a difference that was not statistically significant. However, in the untreated group they found that P3 latency was 437 msec at baseline and 462 msec at follow-up.
Among the 21 subjects available for follow-up at 2 years, they observed that the P3 latency increased in the untreated subjects, but remained stable in the treated patients.
"To our knowledge," they write, "this is the first prospective longitudinal study to demonstrate a beneficial effect of antiviral treatment on AIDS dementia." These findings "...suggest that zidovudine has a positive impact on AIDS dementia as measured by ERP."
In yet another study, researchers claim that "brain atrophy" is detectable even in early asymptomatic HIV infection and it progresses with disease stage, according to a report in the February issue of the Archives of Neurology.
Dr. Igor Grant of the VA Medical Center in San Diego, California, and members of the HIV Neurobehavioral Research Center group performed multiple serial brain magnetic resonance imaging studies in 86 HIV-positive and 23 HIV-negative men. They classified the HIV-positive subjects as follows: 33 in CDC stage A, 19 in stage B, and 34 in stage C.
Dr. Grant's team found that compared with the HIV-negative subjects, all of the asymptomatic CDC stage A subjects, as well as the CDC stage C subjects, had a more rapid loss of cortical tissue. However, all of the stage C subjects had more pronounced brain changes. "Accelerated ventricular volume enlargement occurred only men with CDC stage C disease."
Reductions in white matter volume were also more rapid in subjects with stage C disease, compared with subjects with stage A disease. "Of the gray matter regions, only the caudate nucleus sustained accelerated volume loss during CDC stage C disease.
Dr. Grant's team found that increase in ventricular volume and decrease in the caudate nucleus accelerated in patients who progressed to a higher CDC stage.
HIV entrance into the central nervous system during primary HIV infection, along with neurocognitive dysfunction in early infection have been previously observed, the researchers explain. "Both findings suggest that neuropathologic changes commence during the asymptomatic phase of HIV infection." They suggest that virus-encoded proteins or neurotoxic products of HIV-infected cells may be specific mediators of the changes in brain volume in these patients.
Bisexual transmission significant In heterosexual HIVHIV transmission from bisexual males to their female sex partners may be an under recognized route of heterosexually acquired infection, according to two physicians at the New York City Department of Public Health.
Drs. Thomas Lehner and Mary Ann Chiasson conducted a cross-sectional HIV serosurvey at a New York-based sexually transmitted disease clinic between 1988 and 1993. The findings of their study, which primarily relate to African American and Hispanic patients, appear in the February 1st issue of the American Journal of Epidemiology.
Of the 3,069 male subjects, 415 reported having sex with men. However, the physicians also found that of these 415 men, only 13% were classified as "homosexual," which was defined as having sex with men exclusively. In addition, 35% were classified as "bisexual" and 52% were classified as "heterosexual."
"Although HIV-1 seroprevalence was highest among 'homosexual' men (70%)....it was also high among "bisexual" men (35%)," the researchers point out. In addition to having a high HIV prevalence, the bisexual men also reported infrequent condom use and a large number of male and females partners.
Based on these findings, the physicians suggest "...that HIV transmission from bisexual men to their female sexual partners plays a greater role in heterosexual transmission in African-American and Hispanic communities than was previously recognized." The findings also "...emphasize the need for HIV risk reduction counseling programs that forgo the paradigm of 'gay' versus 'straight' and instead take into account the cultural, ethnic, and behavioral diversity of these men and their sexual partners -- both male and female."
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